FDA.report

N/A

Primary DI
10801741011235
Brand
N/A
Company
C. R. Bard, Inc.
Model
006241P
Catalog number
006241P
Device description
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes
Published
2015-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LDFELECTRODE, PACEMAKER, TEMPORARY

Product Code Classifications

CodeDeviceSpecialtyClass
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741011235PackageGS15In Commercial Distribution
00801741011238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174101123510801741011235
00801741011238008017410112388017410112380801741011238

GMDN Terms

TermDefinition
Intracardiac electrodeAn electrical conductor designed for measuring the electrical activity of and/or to provide pacing signals to the interior of the heart; some electrodes are used to provide electric (e.g., radio-frequency) energy to ablate cardiac tissue. It is usually a very small electrode capable of detecting weak bioelectrical signals and/or to provide high electrical energy; it is typically located at or near the tip of cardiac [e.g., electrophysiology (EP), pacing, ablation] catheters. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge6French
Length125Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com
+1(844)823-5433medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850056280006SoloPace Fusion Ground PadSOLO PACE INC.LDF2026-02-05
00836559001904Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
00836559001911Temporary Myocardial HeartwireOscor Inc.LDF2025-09-15
06947437902535MedtronicSHENZHEN LAUNCH ELECTRICAL CO., LTDLDF2025-02-08
20763000181080NAMEDTRONIC, INC.LDF2024-08-30
20801902216117ARROWTELEFLEX INCORPORATEDLDF2023-07-14
20801902198383ARROWTELEFLEX INCORPORATEDLDF2022-11-18
30836559004692Temporary Myocardial HeartwireOscor Inc.LDF2018-08-17
20884521757544FlexonCovidien LPLDF2018-08-10
20884521757551FlexonCovidien LPLDF2018-08-10
20884521757568FlexonCovidien LPLDF2018-08-10
20884521757575FlexonCovidien LPLDF2018-08-10
30705031245741E-PACKETHICON INC.LDF2018-05-10
30705031245697E-PACKETHICON INC.LDF2018-04-05
30705031242306E-PACKETHICON INC.LDF2017-12-06
30705031241859E-PACKETHICON INC.LDF2017-11-29
20836559004022Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20836559004701Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
20885672102115Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001745Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001752Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001769Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001776Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001790Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001813Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559001899Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559003992Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004609Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
30836559004616Temporary Myocardial HeartwireOscor Inc.LDF2017-11-27
00885672004347TBOscor Inc.LDF2017-11-27